EP2996650A1 - Dispositif de traitement de plaies par pression sous-atmosphérique, présentant une fenêtre ouvrable - Google Patents

Dispositif de traitement de plaies par pression sous-atmosphérique, présentant une fenêtre ouvrable

Info

Publication number
EP2996650A1
EP2996650A1 EP14729229.6A EP14729229A EP2996650A1 EP 2996650 A1 EP2996650 A1 EP 2996650A1 EP 14729229 A EP14729229 A EP 14729229A EP 2996650 A1 EP2996650 A1 EP 2996650A1
Authority
EP
European Patent Office
Prior art keywords
wound
care device
wound care
covering element
negative pressure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP14729229.6A
Other languages
German (de)
English (en)
Other versions
EP2996650B1 (fr
Inventor
Birgit Riesinger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BSN Medical GmbH
Original Assignee
BSN Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102013105063.8A external-priority patent/DE102013105063A1/de
Application filed by BSN Medical GmbH filed Critical BSN Medical GmbH
Publication of EP2996650A1 publication Critical patent/EP2996650A1/fr
Application granted granted Critical
Publication of EP2996650B1 publication Critical patent/EP2996650B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00182—Wound bandages with transparent part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00544—Plasters form or structure
    • A61F2013/0057—Plasters form or structure with openable cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00574—Plasters form or structure shaped as a body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00731—Plasters means for wound humidity control with absorbing pads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00902—Plasters containing means
    • A61F2013/00936—Plasters containing means metal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing

Definitions

  • a wound care device for the treatment of wounds by means of atmospheric negative pressure comprising an openable window
  • the invention relates to a wound care device for the treatment of wounds by means of atmospheric negative pressure, comprising an openable window.
  • Devices for the treatment of wounds by means of atmospheric negative pressure are used, for example, for the postoperative treatment of incisions (it is necessary to dissipate the Nahtwasser and thus allow a faster and less complication seam healing), as well as in the treatment of deep-seated edema, for example in pressure ulcers or ulcus cruris ( here active acquisition of deep wound fluid is a prerequisite for the chronic wound to heal at all).
  • relative underpressures between 60 and 200 mm Hg are used in this therapy form.
  • the apparent window described in EP 1814609 serves to allow a wound contact element, for example an absorption body, or a secondarily arranged care article arranged underneath to be inserted into or removed from the space formed by the gastight wound covering.
  • said wound contact element or said care article can be removed from the wound space - for example for wound cleansing, or for replacement - without having to replace the entire wound care device - which is preferably glued to the wound around the patient's skin. This in turn reduces traumatic intervention during wound care, and is also advantageous for cost reasons.
  • Object of the present invention is therefore to provide a vacuum wound care, which allows the exchange of wound contact elements or care articles, without causing the mentioned disadvantages.
  • a wound care device for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element which can be fastened to the skin of a patient and a connection device for aspirating fluid media, the wound covering element having an openable window, which by means of a gas-tight closure the wound covering element is arranged.
  • Said openable window has a number of advantages. So it allows
  • wound covering element encompasses both completely transparent windows and windows that are not underlaid or lined with a non-transparent material, as well as windows that have a transparent area. It is preferably provided that the wound covering element is preformed corresponding to the anatomical relief of a given body position. This may be useful, for example, if the wound covering element is to be applied in the region of the crook of the arm, the hip or the knee. In particular, by means of deep-drawing methods, in particular, the wound-covering element can be preformed in accordance with the anatomical relief of said body positions.
  • the wound covering element is designed such that it can follow the movement given body position by.
  • the wound covering element and also the gas-tight closure can be designed to be elastic.
  • a pleating or one or more expansion bellows may be provided.
  • Said gas-tight closure is preferably carried out in the form of a groin closure.
  • inguinal closure includes all types of apparent, positive-locking closures which function according to the tongue and groove principle.
  • lips are provided on the two workpieces which are to be connected to one another by means of a closure, which engage in a form-fitting manner when closing.
  • Said lips are preferably made of elastic materials, for example rubber, rubber, polyethylene or polypropylene.
  • Such closures are known, for example, from resealable carry-on bags for the transport of cosmetics in the aviation, resealable storage bags for frozen storage, or resealable stock ("Tupperware").
  • the said grouser closures are also known under the pseudonyms "Ziplock", "Minigrip” or sliding closure. In the latter case, a slider may be provided, which slides similarly to a zipper along the lips to be closed and urges them into the closed position.
  • so-called bead closures as described for example in WO03013976A1, fall under the term "strip closure".
  • said closures are apt to close said openable window in a closed state in a gastight manner, and also have a low overall height and a low weight, and moreover require a small force when closing or opening. In this way, the opening or closing without pain can be exercised.
  • the latter can be accomplished, for example, by an embodiment with a slider (see Fig. 9 and description) or a version with a rear handle shabilitkeit (see Fig, 4 and description).
  • said gastight closure is designed in the form of a magnetic closure.
  • Said magnetic closure has similar advantages in terms of operability. It can also be designed to be gas-tight. It can also be technically designed so that it maintains its gas-tightness even under the aforementioned difficult conditions.
  • said gas-tight seal is designed in the form of a seal / adhesive seal. Two foils are sealed tightly together in a sealed zone. With a pull-tab, the first film can be easily pulled from the second film; The adhesive layer integrated in a depression is thereby exposed.
  • a carrier layer of polyester, a pressure-sensitive adhesive and a sealing layer with integrated migration barrier form the components of the lower film.
  • the strengths are between 200 - 500 ⁇ .
  • Said seal / adhesive seal is known for example from EP2067717 and has similar advantages in terms of operability. It can also be designed to be gas-tight. It can also be technically designed so that it maintains its gas-tightness even under the aforementioned difficult conditions.
  • said gas-tight closure is designed in the form of a hook-and-loop fastener, optionally with an inner sealing lip. is executed.
  • Said Velcro fasteners have similar advantages in terms of operability. It can also be designed to be gas-tight. It can also be technically designed so that it maintains its gas-tightness even under the aforementioned difficult conditions.
  • said gas-tight closure is designed in the form of a sealing rubber or a tube rubber, if necessary with a pressurization.
  • said gas-tight closure is designed in the form of a cork strip, if necessary with a pressure suppression.
  • Said pressurization can be carried out for example by means of a strap or the above-mentioned hook and loop fastener.
  • said gas-tight closure is designed in the form of an adhesive closure, for example with a low-adhesion silicone adhesive, which is applied to the frame or the window side, preferably in the form of a film or a coating.
  • an acrylate adhesive can be used. Both have in addition to favorable sealing and adhesive properties the advantage that they are physiologically harmless.
  • the wound covering element can be fastened to the skin of a patient by means of an adhesive material.
  • an adhesive material Any type of physiologically acceptable adhesive may be used, in particular all medical adhesives.
  • the material is selected from the group containing
  • Zinc oxide adhesive and / or
  • Hydrocolloid adhesives usually consist of a thin polymer film which is applied to a self-adhesive mass.
  • vehicle eg synthetic rubbers such as polyisobutylene
  • swelling particles which are slightly different depending on the manufacturer.
  • source particles such as carboxymethylcellulose or sodium carboxymethycellulose are included.
  • they are especially easy to model after heating.
  • Hydrocolloid adhesives work very well in two-dimensional webs and in particular have the ability to remove moisture. They are available in pasty form, but also in plate and sheet form. Something similar applies to silicone materials. In the case of the latter, in particular the degree of adhesion to the skin can be adjusted very well, so that an atraumatic dressing change can be ensured despite secure adhesion.
  • Such a silicone adhesive may preferably be in the form of a removable adhesive laminate which comprises a structural layer which carries a hydrophobic gel, for example in the form of a silicone gel, on the wound-facing side and a pressure-sensitive adhesive, for example in the form of an acrylate adhesive, on the side facing away from the wound.
  • a hydrophobic gel for example in the form of a silicone gel
  • a pressure-sensitive adhesive for example in the form of an acrylate adhesive
  • said adhesive material is designed in the form of a "border dressing" as an adhesive edge, which peripherally surrounds the wound cover selement. It can also be provided that said adhesive material is designed in the form of a plate or a web on which the wound cover is selement distally arranged. In this embodiment, for example, it may be provided that said plate or track has a central opening which comes to rest over the wound. Said plate or track is then designed as a frame. Alternatively it can be provided that said plate or track is designed so that a window can be cut into the plate or web according to the contour of the wound. For this, e.g. The contour of the wound should be recorded and then cut out with scissors. Likewise, a template can be used, with the aid of which the wound contour can be transferred to the plate or web, or by means of which the wound contour on the plate or the web can be cut out.
  • Said plate or frame for example, consists of a hydrocolloid material as described herein.
  • Said web consists for example of a so-called incision foil. This is a self-adhesive film made of a polymer material.
  • Said plate or said frame is alternatively made of a foam material and / or Ab stand ge act. This may preferably be incorporated in a gas-tight envelope.
  • the above-mentioned adhesive can be provided on the skin side.
  • the device further comprises a wound exudate absorbing absorbent body.
  • wound exudates promoted by the negative pressure therapy do not have to be completely transferred into an external canister, but remain at least partially in the wound space. They can be removed by simply replacing the absorbent body and, being bound in the absorbent body, disposed of more easily and hygienically than an exudate-filled canister.
  • the hereduch possible waiver of an external canister has other advantages; so the device can be designed so that the patient remains mobile (i.e., he can leave the bed and follow a normal everyday life)
  • the absorption body has at least one superabsorbent substance, a modified cellulose, a foam and / or an alginate.
  • the absorption body further comprises a nonwoven comprising cellulose fibers.
  • Superabsorbent polymers are plastics that are able to absorb many times their own weight - up to 1000 times - in liquids. Chemically, it is a copolymer of acrylic acid (propionic acid, C3H4O2) and sodium acrylate (Sodium salt of acrylic acid, NaC 3 H 3 02), wherein the ratio of the two monomers may vary.
  • a so-called core crosslinker core-crosslinker, CXL
  • CXL core-crosslinker
  • the superabsorbent polymers can be present in the wound care article according to the invention in the form of a granulate, a powder, a bed, a compact, a foam, in the form of fibers, a fiber knitted fabric, nonwoven fabric and / or a fiber wadding.
  • Modified cellulose is preferably derivatives of cellulose, preferably sulfoalkylated cellulose and derivatives thereof, preferably cellulose ethylsulfonates, carboxyalkylated cellulose, preferably carboxymethylcellulose, carboxyethylcellulose and / or carboxypropylcellulose, more complex cellulose derivatives, such as sulphoethylcarboxymethylcellulose, carboxymethylhydroxyethylcellulose, hydroxylated cellulose. propyl methyl cellulose, and amidated cellulose derivatives such as carboxymethyl cellulose amide or carboxypropyl cellulose amide.
  • Carboxymethylcellulose in particular is in the form of sodium carboxymethylcellulose and is commercially available under the name "Hydrofiber".
  • the fibers are transformed into a flat matrix.
  • the fibers are gradually transformed into a gel pad that holds the fluid and does not release it again.
  • the fibers are constructed so that the wound exudate is absorbed only in the vertical direction. This means that, as long as the capacity is sufficient, the exudate does not flow over the edge of the wound. In this way, wound edge maceration can be effectively prevented.
  • hydroactive polymers may also be alginates.
  • Alginates are extracted from brown algae and woven into a fibrous web. Chemically they are polysaccharides, namely calcium and / or Natrimsalze the alginic acids.
  • Algi- nates can absorb up to 20 times their own weight of liquid, whereby the wound exudate is stored in the cavities.
  • the Ca2 + ions contained in the alginate lattice are exchanged with the Na + ions from the exudate until the saturation level of Na ions in the alginate is reached. This leads to a swelling of the wound dressing and the conversion of the alginate fiber into a gel body by swelling of the fibers.
  • said hydroactive polymers may also be hydrogel nanoparticles comprising hydroxy-terminated methacrylate monomers, such as 2-hydroxyethyl methacrylate (HEMA) and / or 2-hydroxypropyl methacrylate (HPMA), e.g. marketed as Altrazeal act.
  • HEMA 2-hydroxyethyl methacrylate
  • HPMA 2-hydroxypropyl methacrylate
  • the absorption body has a proportion of> 40% by weight of superabsorbent polymers.
  • the weight fraction of the superabsorbent polymers is particularly preferably> 45, 50, 55, 60, 65 or 70% by weight.
  • the absorption body further comprises a nonwoven comprising cellulose fibers.
  • the absorbent body may preferably comprise a substantially flat absorbent body of absorbent material consisting of an absorbent web having superabsorbent polymers dispersed therein. These may be in the form of granules, a powder, a bed, a compact, a foam, in the form of fibers, a fiber knitted fabric, nonwoven fabric and / or a fiber wadding.
  • the absorption body has at least one material which is selected from the group comprising a mat, in particular an airlaid of said yarns or fibers.
  • superabsorbent polymers with incorporated superabsorbent polymers, and / or a loose filling of superabsorbent polymers.
  • Said Airlaid mat may preferably have a substantially flat material portion of absorbent material, the z. B. consists of an absorbent fleece of said fibers with superabsorbent polymers distributed therein.
  • This absorbent body may correspond to the absorbent pad contained in a wound dressing of the Applicant of the present invention, as disclosed, for example, in WO03094813, WO2007051599 and WO0152780 and sold under the trade name "sorbion sachet.”
  • the disclosure of said references be fully attached to the disclosure of this document.
  • the absorbent body can also form a core which has fibers or yarns of superabsorbent polymers and superabsorbent polymers in granulate form, if appropriate flake-like, the granules being adhesively bonded or welded to the fibers or yarns at several heights , and the granules are distributed over more than 50% of the total height of at least a portion of the core, wherein there are mixed areas of granules and fibers.
  • the weight fraction of the superabsorbent polymers may preferably be in the range between 10 and 25% by weight. Similar constructions are known from conventional incontinence materials and known as sanitary napkins for their cushioning properties.
  • a shell may be arranged around said core, which is arranged overlapping in regions and which, for example, covers or is part of an adhesive seam.
  • the absorption body particularly preferably has a fleece, preferably a nonwoven or airlaid, which consists of superabsorbent fibers ("SAF", preferably polyacrylates) or contains these as constituent.
  • SAF superabsorbent fibers
  • the fibers can, for example, be treated with fluff pulp (cellulose pulp). se) or mixed with polyester fibers. Alternatively or additionally, a layer structure may be provided.
  • Construction 1 layer on 40% Bicompo layer Thermoge- 25% 40% Polybau: Ther- Polyester nentenmoi bondetes Airlaid with lamiPolyester; short cotton short-cut SAF ned nonwoven 75% SAF cut fiber; It has a 60% SAF laid with water; 60% Thermolaminated SAF plastic
  • the absorption body may also comprise at least one flat layer comprising fibers or yarns of superabsorbent polymers to which superabsorbent polymers are glued in granular form.
  • a structure of the body having at least three layers, wherein two cover layers surrounding a layer having superabsorbent polymers.
  • the body may have repetitive patterns or grains, such as a checked pattern, a punching pattern, or the like.
  • said absorption body has a surface mass of 5 ⁇ 5, 5 ⁇ 10, 5 ⁇ 20, 10 ⁇ 10, 10 ⁇ 15, 10 ⁇ 20, 15 ⁇ 15, 20 ⁇ 20 or 20 ⁇ 40 cm.
  • said absorbent body has, in addition to a layer of superabsorbent polymers, at least one second flanking layer which has fewer or no superabsorbent polymers and extends in terms of area beyond the former.
  • Suitable foams are both closed and open-cell foams. These are preferably also configured as a flat layer and have, on the one hand, liquid-absorbing properties and, on the other hand, cushioning properties. In addition, they have high restoring forces. In particular, so-called cold foams are preferably used.
  • nanofiber matrixes As an alternative or in addition to said foam, it is also possible to use so-called “nanofiber matrixes”, as are produced, for example, by the company SNS Nano Fiber.
  • said foams can also be mixed with superabsorbers, as has been done, for example, in the product Allevyn Plus from Smith & Nephew.
  • the device further comprises a wound-facing liquid-permeable wound spacer grid.
  • Such a wound spacer grid is preferably a plastic grid (preferably comprising, for example, a silicone material or a nylon material), a perforated foam, a spacer knit and / or a perforated foil.
  • a three-dimensional wound distance grid is provided, as described for example under the brand name "sorbion plus” on the market and in EP2004116A1.
  • the wound distance grid may on the one hand be provided on the wound side, and may be both loosely locatable within the frame and fixed on the frame.
  • Such a wound distance grid prevents the granulation and thus allows atraumatic dressing change, further has a biofilm dissolving effect and also has a valve effect such that reflux of exudate is reduced.
  • connection device for sucking in fluid media can in principle be designed so that it allows the aspiration of liquids and / or gases.
  • it can be configured, for example, in the form of a coupling (for example, according to the Luer-Lock system), which allows the connection of a hose and / or a pump.
  • the product may have an additional valve, a pressure reducer or even another revealable window.
  • a pressure reducer or even another revealable window. This makes it possible to ensure that the device can also be used in the event of excessive negative pressure, for example with a vacuum connection in the wall, which is often provided in hospitals. Said valve, pressure reducer or reveal window can then be opened to reduce the negative pressure.
  • a barrier is arranged, which does not allow liquids to pass. This ensures that no liquid gets into the pump. The latter remains within the wound cover and is absorbed by wound exudates absorbing absorbent body
  • Said barrier preferably has a semipermeable membrane, for example of a material such as Goretex, etc.
  • a connecting device for sucking liquid media and a connecting device for sucking gaseous media be proceed.
  • the device further comprises means for generating atmospheric negative pressure.
  • Said device for generating atmospheric negative pressure is preferably selected from the group comprising a) electrically operated vacuum pump
  • the said vacuum pump may be a solitary pump, but it may also be part of a centralized suction system, as is often used in clinics.
  • wall-mounted vacuum connections are provided in the patient rooms, to which the fiction, contemporary drainage devices for wound treatment can be connected.
  • said vacuum pump can vacuum a plurality of wound treatment drainage devices according to the invention.
  • it is a micropump whose dimensions and / or weight is such that it can be easily attached to a wound covering element of the type mentioned, without this being annoying to the patient or disturbing him in any way.
  • This pump can be for example of the type piezo or diaphragm pump.
  • piezo pumps ie pumps, in which the pumping power is accomplished by a piezoelectric element.
  • These pumps have a sufficiently high pump power with small dimensions, low operating noise and low energy consumption.
  • it may be a propellant vacuum pump manufactured in microsystem technology. Suitable pumps of this type are manufactured, for example, by Schwarzer Precision, KNF or Bartels Mikrotechnik.
  • a pump is further equipped with a check valve. In this way, the pump can be operated in the interval mode or only for the initial construction of the negative pressure or to maintain the negative pressure can be switched on without leaks occur in the breaks, which reduce the negative pressure built up again.
  • said pump is capable of drawing negative pressures of -60 to -200 mm Hg.
  • the pump is provided with negative pressures of -60, -70, -80, -85, -90, -100, -110, -120, -130, -140, -150, -160, -170, -180, -190 or - 200 mm Hg pulls.
  • the pump is chosen or designed so that it is able to carry liquids.
  • the operating noise of the pump does not exceed a sound pressure level of 65 dB.
  • a sound pressure level of 63 dB, 60 dB, 58 dB, 55 dB, 53 dB, 50 dB, 48 dB, 45 dB, 42 dB, 40 dB, 38 dB, 35 dB, 32 dB, 30 dB, 28 dB , 25 dB 22 dB, or even 20 dB not exceeded.
  • the pump has a delivery rate between 0.5 ml min "1 and 100 ml min " 1 .
  • Preferred delivery rates are between 2 ml min “1 and 50 ml min “ 1 .
  • Particularly preferred are delivery rates between 10 ml min “1 and 20 ml min " 1
  • Said evacuated vessel can be connected similar to the known redone bottle to the device according to the invention for wound treatment and put them under negative pressure.
  • Said evacuated vessel has a liner containing liquid-absorbent polymers, preferably in the form of a wall lining.
  • said evacuated vessel can be provided in the form of a cartridge which is inserted into a holder which is already equipped with the drainage device according to the invention. for wound treatment. When the cartridge is full, it is removed and disposed of, and a new evacuated cartridge can be placed in the holder.
  • the device is mobile and independent of the mains, so that the patient himself is mobile.
  • an anatomically adapted configuration of the said evacuated vessel or the mentioned holder is advantageous, which allows unobtrusive carrying of the same, for example on the leg.
  • the device for generating atmospheric negative pressure is arranged directly on the wound care device.
  • a coupling, a shut-off valve and / or a three-way cock is arranged between the device for generating atmospheric negative pressure and the wound cover selement or the absorbent exudation absorbent body
  • this device By means of this device it can be ensured that a) the device for generating atmospheric negative pressure can be decoupled from the rest of the device, b) a vacuum drawn once is kept as long as possible and / or c) for the purpose of protecting the battery or discharging the battery via a External pump or an external vacuum vessel initial or a negative pressure can be applied again.
  • Said external pump or said external vacuum vessel may, for example, be at home in the clinic or at the patient, or may be in mobile form (for example, in the form of a suitcase, integrated into the patient's clothing or attached to the patient via a belt). This ensures that the device on the wound remains small and inconspicuous - since their job is primarily to maintain the vacuum, but if necessary, sufficient pumping capacity is available to ensure efficient therapy.
  • the absorption body is surrounded by a liquid-permeable casing.
  • the device further comprises a spacer body. This can preferably be placed between the wound and the wound covering element, but also - if present - between the absorbent body and the wound covering element or between the wound and the absorbent body.
  • Such an abutment body ensures that the wound care device does not completely collapse upon application of negative pressure, which would result in gases or liquids not being able to be further aspirated.
  • the device further comprises a layer comprising a heavy metal, preferably copper or silver, or a salt thereof. Especially with regard to an extended stay on the wound, such a situation can be very helpful as it slows down bacterial growth.
  • the wound covering element is liquid and / or gas impermeable.
  • said wound covering element is elastic.
  • it may for example comprise a polypropylene, polyethylene, latex, silicone or rubber material.
  • it can also be provided on the inside with a foam material.
  • the wound covering element is water vapor permeable.
  • the wound covering element is further formed transparent.
  • the device for generating atmospheric negative pressure in its pumping direction is reversible.
  • the device can also be used as a controllable metering pump for drugs, rinsing solutions, etc.
  • said apparent window has a non-elastic back wall.
  • rear wall is meant the lid per se, as witnessed for example in reference numeral 23.
  • the discussed pump may be located directly on the rear wall of the revealable window.
  • said openable window has an elastic rear wall.
  • the window follows the movements of the patient and thus the tightness is guaranteed.
  • This elastic rear wall preferably comprises or consists of a silicone material. Particularly preferably, for example, be provided that the underside of the rear wall - ie the patient-facing side - coated with a silicone and / or a foam material or lined with such a material.
  • said openable window has a rear wall made of a plastically deformable material.
  • the rear wall consists of a thermoformable deep-drawing film.
  • a reservoir can be provided within which, for example, a reserve absorption body can be provided.
  • a wound care device for treating wounds having soft tissue defects, infected wounds after surgical debridement, lymphatic fistulae, sternal wound infections, thoracic wall windows, decubitus, ulcus cruris, chronic wound healing disorders, radiation ulcer, abdominal compartment syndrome, septic abdominal wall, enteral fistulas and / or wounds. which are caused by one or more edema, intended for the fixation of skin grafts, for wound conditioning and / or for the postoperative care of sutures and incisions.
  • a wound care device according to one of the preceding claims in a wound compression system is further provided.
  • pictures 1 shows the general principle of a wound care device for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 3 which can be fastened to the skin of a patient, and a connecting device (not shown) for aspirating fluid media.
  • the wound-covering element has an openable window 23, which is arranged on the wound-covering element by means of a gastight closure (not shown). After opening the window 23, a wound dressing 2 can be easily removed, disposed of and replaced with another dressing.
  • Fig. 2 shows an openable window 10 comprising a frame 12, a connecting plate 36 between the frame 12 and window cover 46, and a gas-tight closure in the form of a bar fastener 18, 40.
  • said strip closure 18, 40 shown in cross-section in detail ,
  • Fig. 4 also shows an openable window with a groin closure 42, 43.
  • Said inguinal closure is provided with a rear grip possibility, which ensures that the inguinal closure requires a small force when closing or opening. In this way, the opening or closing without pain can be exercised.
  • the closure has a low height and a low weight.
  • 5 a shows another form of a strip fastener which can be used according to the invention in the form of a slider 38, which, similar to a zipper, slides along the lips to be closed and forces them into the closed position.
  • Fig. 5b shows a gas-tight closure in the form of a seal / adhesive seal.
  • 6 shows a wound care device 60 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 61 which can be attached to the skin of a patient and a connection device 62 for aspirating fluid media.
  • the wound covering element has an openable window 63, which is arranged on the wound covering element by means of a gas-tight closure.
  • the wound covering element has a circumferential edge 64 comprising an adhesive material 65.
  • a so-called "border dressing” is realized.
  • 7 shows a wound care device 70 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 71 which can be fastened to the skin of a patient and a connecting device, not shown, for sucking in fluid media.
  • the wound covering element has an openable window 73, which is arranged on the wound covering element by means of a gastight seal.
  • the device further includes a plate or frame 74 on which the wound covering element is located distally.
  • said plate or track has a central opening which comes to rest over the wound.
  • Said plate or track is then designed as a frame.
  • said plate or track is designed so that a window can be cut into the plate or web according to the contour of the wound.
  • said plate consists of a hydrocolloid material as described herein.
  • Said web consists for example of a so-called incision film. This is a self-adhesive film made of a polymer material.
  • Fig. 8 shows a wound care device 80 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 81, which on the Skin of a patient is fastened and a connecting device 82 for sucking fluid media.
  • the wound covering element has an openable window 83, which is arranged on the wound covering element by means of a gas-tight closure.
  • the revealable window is provided with a pressure-resistant wall and provides space for an absorbent body 84 comprising superabsorbent polymers. Due to the pressure resistance, the apparent window does not collapse, so that the absorption body can exploit its full absorption capacity.
  • a passage body 85 made of a foam material and a three-dimensional wound spacer grid 86 are provided on the wound side.
  • FIG. 9 shows a wound care device 90 for treating wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 91 which can be fastened to the skin of a patient, and a connection device 92 for aspirating fluid media.
  • the wound covering element has an openable window 93, which is arranged on the wound covering element by means of a gas-tight strip closure 94.
  • the begotten groin closure is also known under the pseudonyms "Ziplock”, “Minigrip” or GleitverInstitut. It has a low height and a low weight and also requires a small force when closing or opening.
  • a compartment 98 with a pressure resistant wall that provides space for an absorbent body 95 comprising superabsorbent polymers.
  • Said compartment is formed liquid-permeable to the wound side. Due to the pressure resistance, the compartment does not collapse, so that the absorption body can exploit its full absorption capacity. Once this is achieved, the entire window, including the Tray and the absorption body contained therein discarded and replaced with a new one.
  • a passage body 96 made of a foam material and a three-dimensional wound distance grid 97 are provided on the wound side.
  • the flow body is - unlike the compartment 98 - housed not resistant to pressure and therefore reduced when pressure is applied to its volume.
  • FIG. 10 shows a wound care device 100 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound cover 101, which can be attached to the skin of a patient, and a connection device 102 for aspirating fluid media.
  • the wound-covering element has an openable window 103, which is arranged on the wound-covering element by means of a gastight inguinal closure 104.
  • the begotten groin closure is also known under the pseudonyms "Ziplock”, “Minigrip” or GleitverInstitut. It has a low height and a low weight and also requires a small force when closing or opening. Further, an absorption body 105 is provided, which can be removed or introduced after opening the window.
  • Ia shows a wound care device 110 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 111, which can be fastened to the skin of a patient, and a connection device 112 for aspirating fluid media.
  • the wound covering element has an openable window 113, which is arranged on the wound covering element by means of a gastight inguinal closure 114.
  • the begotten groin closure is also known under the pseudonyms "Ziplock”, “Minigrip” or GleitverInstitut. It has a low height and a low weight and also requires a small force when closing or opening.
  • a net 115 which offers space for an absorption body, not shown, for example comprising superabsorbent polymers.
  • Said absorption body can be inserted into the net, whereupon the openable window can then be fastened to the cover element by means of the strip closure. After reopening the window, the absorbent body can be removed and disposed of or replaced, for example, when it has reached its full absorption capacity.
  • a further absorption body 116 is provided on the wound side, possibly having a lower liquid retention than the abovementioned absorption body.
  • FIG. 1b shows a device similar to FIG. 11a, with the difference that an absorption body 118 is attached to the wound-side window 117 on the wound side. Has the latter reached its full capacity, the entire window can be disposed of together with the attached absorbent body and replaced with a new one.
  • Fig. 12 shows a wound care device 120 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element, which can be fastened to the skin of a patient, and a connection device 122 for aspirating fluid media.
  • the wound-covering element has an openable window 121 which is arranged on the wound-covering element by means of a circulating evacuatable channel 123.
  • FIG. 13 shows a further embodiment of a gas-tight closure in the form of a sealing / adhesive seal.
  • a wound care device 140 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element which can be fastened to the skin of a patient, as well as a connecting device (not shown) for aspirating fluid media.
  • the wound covering element has an openable window 141, which can be fastened to the wound covering element by means of a hook and loop fastener 142.
  • a circumferential tube rubber 143 is further provided that is acted upon by the Velcro with pressure and thus leads to a gas-tight seal.
  • a sealing rubber, a cork band or the like may also be provided.
  • a hinge 144 is provided, which connects the openable window on one side with the wound covering element, so that the latter can only be unfolded, but not removed in its entirety.
  • a wound care device 140 for the treatment of wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element which can be fastened to the skin of a patient, as well as a connecting device (not shown) for aspirating fluid media.
  • the wound covering element has an openable window 151 which can be fastened to the wound covering element by means of a magnetic closure 152.
  • a circumferential rubber tube 153 is further provided in the middle, that is acted upon by the Velcro with pressure and thus leads to a gas-tight seal.
  • a sealing rubber, a cork band or the like may also be provided.
  • FIG. 16a shows the arrangement of the wound care article according to the invention with an absorption body 80 with an elastic foil-like element 81 and / or an elastic sheath 82 on a deep wound 83, at whose wound base 84 exudate 85 stands.
  • the shell 82 may be an integral part of the foil-like element at least in sections - for example in the area away from the wound. It is ensured by the elastic film-like element 81 and / or the elastic shell 82 that the absorption body can be pulled or pressed against the wound base 84 (indicated by the arrows) when a negative pressure is applied, which is necessary in particular for deep wounds make contact with the male exudate 85.
  • Fig. 16b shows a similar arrangement as Fig. 16a, but at a later time.
  • the absorption body 80 has already absorbed large amounts of exudate.
  • the elastic film-like element 81 and / or the elastic sleeve 82 ensures that the latter does not oppose the expansion of the absorption body due to the absorption of liquid. This ensures that the absorption body can play its full absorption capacity.
  • the coupling device 86 (and thus the vacuum device, not shown, connected thereto) may already be uncoupled, or else the vacuum device is turned off and no longer draws any negative pressure.
  • the application of a negative pressure merely serves to attract or press the absorbent body against the wound base 84 so as to establish contact with the exudate to be absorbed. Once this contact is made, it may be provided to disconnect or disconnect the vacuum device.
  • FIG. 17 Another embodiment is shown in FIG. 17.
  • a foam body is provided, which has a recess for the exact fit receiving a vacuum source, such as a pump.
  • a non-illustrated check valve is preferably placed in a through-opening 57. Said foam body covered by the wound covering element, not shown.
  • FIG. 18 shows a cross-section through a frame 180 of a wound-covering element according to the invention.
  • the frame consists, for example, of a foam material 181 laminated into a gas-tight base sheet 182 and a gas-tight cover sheet 183 laminated thereon.
  • the former forms the contact surface with the patient's skin and is coated, for example, with an adhesive as elsewhere coated therein.
  • the latter forms the bearing surface for the revealable window. It can preferably be made disinfectable.
  • Figs. 19-22 show concretized embodiments of the wound care device according to the invention.
  • FIG. 19 shows a wound care device for treating wounds by means of atmospheric negative pressure in the wound area, comprising a wound covering element 191 in the form of a frame, which can be fastened to the skin of a patient via an underlaid film 194, for example by means of a physiologically acceptable adhesive, wherein the wound covering element has visible window 192 which is arranged by means of a gas-tight closure - for example, a coating of low-adhesion silicone - on the wound covering element.
  • the wound covering element for example, in a gas-tight Material laminated foam material or a spacer on.
  • the window has a backing comprising, for example, a foam material or a spacer knitted fabric sealed by a gas-tight film or coating.
  • a pump 193 is shown, which is connected via a connection device for aspirating fluid media to the wound care device.
  • the apparent window 192 has a recess in its material for snugly receiving one of the pump 193.
  • the pump 193 is designed to be removable, as can be seen in FIG.
  • FIG. 21 shows the wound care device in an exploded view with the wound covering element 211 in the form of a frame which can be fastened to the skin of a patient via an underlaid foil 214, for example with the aid of a physiologically harmless adhesive.
  • the foam material or stand-up knit 215 of the wound-covering element 211 is also sown.
  • FIG. 21 also shows the apparent window 212, which is arranged on the wound covering element by means of a gas-tight closure, for example a coating of low-adhesion silicone, and the foam material or spacer fabric underlying the window 216, which is of gas-tight Foil or coating is completed.
  • a gas-tight closure for example a coating of low-adhesion silicone
  • the pump 213 which is connected via a connecting device for aspirating fluid media to the wound care device, recognizable, as well as the recess in the window for snug receiving a pump.
  • a wound spacer grid 217 is shown that either (i) can be provided on the wound side, and both can be arranged loosely within the frame and fixed on the frame, or (ii) can be provided on the lid side.
  • Fig. 22 shows another wound care device for the treatment of wounds by means of atmospheric negative pressure in the wound area, in which case the pump is designed as a hand-operated pump.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de traitement de plaies par application d'une pression sous-atmosphérique dans la zone de la plaie, ledit dispositif présentant un élément de recouvrement de plaie pouvant être fixé sur la peau d'un patient, et un dispositif de raccordement destiné à l'aspiration d'agents fluides, l'élément de recouvrement de plaie présentant une fenêtre ouvrable qui est située sur l'élément de recouvrement de plaie au moyen d'un élément de fermeture étanche au gaz. (Fig. 4b).
EP14729229.6A 2013-05-16 2014-05-16 Dispositif de soin de plaies pour le traitement des plaies au moyen d'une dépression atmosphérique, comprenant une fenêtre ouvrable Active EP2996650B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102013105063.8A DE102013105063A1 (de) 2013-05-16 2013-05-16 Wundpflegevorrichtung zur behandlung von wunden mittels atmosphärischem unterdruck, aufweisend ein öffenbares fenster
DE102013107399 2013-07-12
PCT/EP2014/060133 WO2014184366A1 (fr) 2013-05-16 2014-05-16 Dispositif de traitement de plaies par pression sous-atmosphérique, présentant une fenêtre ouvrable

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EP2996650A1 true EP2996650A1 (fr) 2016-03-23
EP2996650B1 EP2996650B1 (fr) 2024-09-04

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US (1) US11154426B2 (fr)
EP (1) EP2996650B1 (fr)
JP (1) JP2016524490A (fr)
CN (2) CN105338934A (fr)
AU (1) AU2014267236B2 (fr)
BR (1) BR112015028665B1 (fr)
CA (1) CA2914655C (fr)
WO (1) WO2014184366A1 (fr)

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Publication number Publication date
US20160135998A1 (en) 2016-05-19
AU2014267236B2 (en) 2019-05-16
CA2914655C (fr) 2023-07-25
JP2016524490A (ja) 2016-08-18
WO2014184366A1 (fr) 2014-11-20
US11154426B2 (en) 2021-10-26
CN105338934A (zh) 2016-02-17
BR112015028665A2 (pt) 2018-06-05
CN113509316A (zh) 2021-10-19
BR112015028665B1 (pt) 2022-09-13
CA2914655A1 (fr) 2014-11-20
AU2014267236A1 (en) 2015-12-10
EP2996650B1 (fr) 2024-09-04

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